New CTTI Publication Investigates Best Practices for Driving Adoption of Master Protocols

In a new publication, CTTI applies expertise from industry sponsors, regulatory agencies, patient groups, and academic institutions to identify best practices for driving the widespread adoption of master protocols. Master protocol studies use a single protocol to guide the design and conduct of multiple sub-studies that can answer several questions at once—enabling patient-centric and efficient clinical research. Despite these benefits, adoption of master protocol studies remains limited. To facilitate broader adoption, CTTI conducted a landscape review and collected insights from multi-stakeholder expert meetings. Through these efforts, CTTI identified a broad set changes in the clinical trials ecosystem that would be needed for mainstream adoption master protocol studies: (1) the development of a harmonized global vision, (2) mobilization through the leadership of patients and academic groups, and (3) reinvention of operational processes and partnerships. The full publication, available in Clinical Trials, discusses the barriers to widespread adoption of master protocol studies and details potential solutions. The paper also highlights a suite of tools that CTTI has developed to support the design and conduct of high-quality, efficient master protocol studies.